Lyme disease is a systemic tick-borne illness generally characterized as a reddish or purplish target rash radiating around the tick bite. Lyme disease is generally characterized as being caused by a spirochete bacteria Borrelia burgdorferi. Various sub-species and strains of this organism have been identified, but their inter-relationship is not finally determined.
The diagnostic acumen for Lyme Disease is poor. The ability to quickly and reliably detect the presence of Borrelia burgdorferi in patients suspected of having Lyme Disease is of great medical importance. The in-vitro culture of Borrelia burgdorferi is currently the most effective technique but is an impractical method of diagnosis.
A technique for detecting the presence of the organism Borrelia burgdorferi by utilizing antibodies specific for at least one antigen of the organism is described in U.S. Pat. No. 4,888,276. The use of other monoclonal and polyclonal antibody tests for detection of Borrelia burgdorferi antigens is described in the JOURNAL OF CLINICAL MICROBIOLOGY, June 1991, page 1162-1170. However, immunological methods are neither sufficiently sensitive nor reliable for diagnostic screening.
Molecular biological techniques have also been attempted. PCR (Polymerase Chain Reaction) amplification and subsequent hybridization of amplified material with radiolabeled probe has been reported in the JOURNAL OF CLINICAL MICROBIOLOGY, June 1990, page 1089-1093 and in the JOURNAL OF CLINICAL MICROBIOLOGY, April 1991, page 731-737. However, this PCR work was not done on clinical samples. In general, the PCR technique works best when amplifying nucleic acid materials present in pure culture or in joint or cerebrospinal fluid. The PCR technique has limited utility in whole blood or plasma samples. Therefore, the amplification technique does not provide an adequate diagnostic method for detection of Borrelia burgdorferi in individuals suspected of having Lyme Disease.